MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Device Problem Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); Swelling/ Edema (4577)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) clinical study.It was reported that ct imaging showed bleeding at the puncture site and stent damage occurred.On (b)(6) 2020 two days before the index procedure, an endovascular therapy (evt) was performed to the right superficial femoral artery (sfa) with placement of two 7mm x 120mm eluvia drug-eluting vascular stents for the treatment of calcification and potential stenosis in the right sfa.Post procedure, the subject complained of swelling at the puncture site.Ct imaging showed bleeding at the puncture site, which might have been from common femoral or sfa.Hemostasis was obtained with 6.0 mm balloon.Angiography revealed no further bleeding.In addition, nitroglycerine was started as subject was on high blood pressure.On (b)(6) 2020, the subject was enrolled into the (b)(6) study and the index procedure was performed on the same day.The target lesion was located in the right anterior tibial with 90% stenosis, proximal and distal reference vessel diameter were at 3.25 mm and 3.25 mm respectively with a length of 140 mm.The target lesion was treated with pre-dilatation followed by placement of two 3.5 mm x 80 mm saval pivotal des btk stents.Post dilation was performed resulting in 0% residual stenosis.Subsequently, the proximal edge of the previously placed eluvia stent in proximal right sfa was found to be damaged.Another 6mm x 40mm eluvia stent was placed over the previous eluvia stent as resolution.No further hemorrhage was seen at the puncture site.On (b)(6) 2020, the subject was discharged on clopidogrel.

• Brand Name: ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11547784
• MDR Text Key: 241738034
• Report Number: 2134265-2021-03649
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR